Medtronic recalls STRATA II shunts and valves for hydrocephalus treatment due to potential variation in radiopaque marking visibility under X-ray imaging. Affected models include specific CFNs and lot numbers listed in the recall.
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
Medtronic is recalling STRATA II shunts and valves used for hydrocephalus treatment because the radiopaque markings might not be visible under X-ray imaging. This could make it harder for doctors to adjust the device properly during medical procedures.
The radiopaque markings on these shunts and valves may not show clearly under X-ray imaging. This could lead to difficulties in adjusting the device during medical procedures, but it does not pose an immediate risk of injury or death.
Patients with hydrocephalus who have the specific STRATA II shunts or valves listed in the recall are affected. Medical professionals using these devices for treatment are also at risk if they need to adjust the device.
Check if your device has a model number starting with 'STRATA II' and matches the specific CFNs listed in the recall. Also, verify the lot numbers provided in the record.
Look for the model number on your device to see if it matches the listed CFNs or lot numbers in the recall.
Reach out to Medtronic directly to confirm if your device is affected and get instructions on next steps.
No, the recall does not require immediate discontinuation. The risk is low and related to X-ray visibility, not immediate injury.
Check the model number on your device against the listed CFNs and lot numbers provided in the recall.
Contact Medtronic directly to get specific instructions for your device.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1116-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1116-2021 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
